Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine
Recruitment status was Not yet recruiting
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Therapy With Bromocriptine in Patients With Symptomatic Risperidone-Induced Hyperprolactinemia|
- Simpson Angus Scale (SAS)
|Study Start Date:||May 2006|
|Estimated Study Completion Date:||May 2008|
Antipsychotic drugs can cause a clinically relevant hyperprolactinemia due to blocking the dopamine receptors in the pituitary.Depending on its concentration hyperprolactinemia causes a median hypogonadism with estrogen insufficiency in women and testosterone insufficiency in men by inhibiting the pulsatile GnRH-secretion.The hyperprolactinemia-induced symptoms have been successfully medicated for years with dopamine agonists like bromocriptine.
In patients with psychiatric diseases hyperprolactinemia is usually not treated with dopamine agonist fearing a reexacerbation of the underline psychiatric disease. In a few studies and casuistically the treatment of neuroleptic-induced hyperprolactinemia with bromocriptine has been shown to be effective without causing reexacerbation of psychotic symptoms.
Schizophrenic patients suffering from a neuroleptic-induced hyperprolactinemia (in extremis galactorrhoea and amenorrhoea. in women, loss of libido and erectile dysfunction in men) will be examined endocrinologically. Adverse drug effects and diagnoses will be confirmed by measuring hormones (prolactin, LH, FSH, testosterone, estradiol). In case of a clear symptomatic, neuroleptic-induced hyperprolactinemia patients will be medicated with bromocriptin. Therapeutical success will be determined endocrinologically in week 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 together with a psychiatric examination (PANSS, HAM-D, Simpson-Angus Scale (SAS)). Safety of therapy will be ensured by the close meshed psychiatric examinations.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315081
|Contact: Kai-Uwe Kuehn, MD||0049-(0)firstname.lastname@example.org|
|University of Bonn, Department of Psychiatry||Not yet recruiting|
|Bonn, Northrhine-Westfalia, Germany, 53105|
|Contact: Kai-Uwe Kuehn, MD 0049-(0)2228-287-5681 email@example.com|
|Principal Investigator:||Wolfgang Maier, MD||University of Bonn, Department of Psychiatry|